Dynamic device manipulation

Abstract

The controller includes at least one processor and a memory coupled to the at least one processor. The memory stores computer executable instructions. The at least one processor is configured to execute the computer executable instructions to cause the controller to determine a clinical drive scenario associated with the transcutaneous device and to set drive characteristics associated with the transcutaneous device based on the clinical drive scenario and information included in the drive profile, wherein the information included in the drive profile includes information associating a particular clinical drive scenario with a particular drive characteristic.

Description

TECHNICAL FIELD

[0001] The present application relates generally to manipulating movement of a percutaneous device, and more particularly to dynamically manipulating movement of a percutaneous device. BACKGROUND

[0002] Percutaneous devices, such as catheters, are often used in conjunction with a bedside system that allows a physician to control movement of the percutaneous device using a drive interface. SUMMARY

[0003] The independent claims set forth the scope of protection sought for various example embodiments. Example embodiments and / or features described in this specification that do not fall within the scope of the independent claims, if any, should be interpreted as examples useful for understanding a variety of embodiments.

[0004] Independent of the use of grammatical terms, a person of either gender is included in the term.

[0005] In various example embodiments, the controller includes at least one processor and a memory coupled to the at least one processor. The memory stores computer-executable instructions. The at least one processor is configured to execute the computer-executable instructions to cause the controller to determine a clinical drive scenario associated with the percutaneous device and set a drive characteristic associated with the percutaneous device based on the clinical drive scenario and information included in a drive profile. The information included in the drive profile includes information associating a particular clinical drive scenario with a particular drive characteristic. In some example embodiments, the at least one processor is further configured to execute the computer-executable instructions to cause the controller to determine the clinical drive scenario based on position information indicative of a distance that the percutaneous device is inserted into the patient.

[0006] The at least one processor can be further configured to execute the computer-executable instructions to cause the controller to determine the clinical drive scenario based on a comparison of a distance that the percutaneous device is inserted into the patient and an estimated length of a blood vessel of the patient. In some such example embodiments, the position information includes at least one of information indicative of a position of an arm of an imaging system relative to the patient, a positioning of the controller relative to the patient, a position of a cartridge along a drive axis of the controller, image recognition of a marker on the patient, or image recognition of a marker on the percutaneous device.

[0007] In any or all of the above example embodiments, the at least one processor is further configured to execute the computer-executable instructions to cause the controller to receive a user control signal from the driver interface, where the user control signal is indicative of a requested movement of the percutaneous device controlled by the controller, and to set a driving characteristic of the percutaneous device by modifying the user control signal based on the clinical driving scenario and information included in the driving profile. The at least one processor can be further configured to execute the computer-executable instructions to cause the controller to determine the clinical driving scenario based on a field of view of the imaging system or at least one of a position of the imaging system relative to the patient, where the field of view of the imaging system represents an area between an entry site where the percutaneous device is inserted into the patient and a patient head.

[0008] In some example embodiments, the information included in the driving profile includes information that defines, establishes, imposes, and / or limits a particular driving characteristic under a particular clinical driving scenario. The particular clinical driving scenario can include at least one of a type of the percutaneous device, a configuration of the percutaneous device, a distance that the percutaneous device is inserted into the patient, or whether a distal portion of the percutaneous device is still entirely within an existing percutaneous device. The particular driving characteristic can include at least one of a peak velocity, a peak acceleration, a jerk, a peak rotational velocity, a peak rotational acceleration, a per input displacement ratio, a maximum absolute displacement, a maximum force, a maximum linear displacement, or a rotational lock. As used herein, the term “jerk” and its derivatives refer to a time rate of change of acceleration.

[0009] In various example embodiments, including any or all of the above example embodiments, the controller includes at least one processor and a memory coupled to the at least one processor. The memory stores computer-executable instructions, and the at least one processor is configured to execute the computer-executable instructions to cause the controller to determine a distance that the percutaneous device is inserted into the patient, receive a user control signal from a driver interface, where the driver interface is configured to control movement of the percutaneous device in response to user interaction with the driver interface, generate an adjusted user control signal based on the distance that the percutaneous device is inserted into the patient, and send the adjusted user control signal to a power device configured to move the percutaneous device in accordance with the adjusted user control signal.

[0010] In some such example embodiments, the at least one processor is further configured to execute the computer-executable instructions to cause the controller to determine the distance that the percutaneous device is inserted into the patient based at least in part on kinematic information, based on a position of the imaging system relative to the patient, and / or based on a positioning of the percutaneous device handling system relative to the patient. In some example embodiments, the at least one processor is further configured to execute the computer-executable instructions to cause the controller to determine the distance that the percutaneous device is inserted into the patient based at least in part on a displacement of a tube housing along a drive shaft of the percutaneous device handling system.

[0011] In any one or all of the above example embodiments, the at least one processor is further configured to execute the computer-executable instructions to cause the controller to generate the adjusted user control signal by changing the user control signal based on at least one of a field of view of the imaging system or a position of the imaging system relative to the patient, wherein the field of view of the imaging system represents an area between an entry site at which the percutaneous device is inserted into the patient and a head of the patient.

[0012] In some such example embodiments, the at least one processor is further configured to execute the computer-executable instructions to cause the controller to generate the adjusted user control signal based on profile information included in the drive profile, wherein the profile information included in the drive profile includes first information associating a distance that the percutaneous device is inserted into the patient with a movement characteristic of the percutaneous device.

[0013] In some such example embodiments, the profile information included in the drive profile further includes second information associating the movement characteristic of the percutaneous device with at least one of a safe loading position of the percutaneous device, a type of the percutaneous device, or a configuration of the percutaneous device. In various example embodiments, the movement characteristic of the percutaneous device includes at least one of a peak velocity limit, a peak acceleration limit, a jerk limit, a rotational velocity limit, a per input displacement ratio, an absolute displacement limit, a rotational lockout, a maximum force limit, or a linear displacement limit.

[0014] In various example embodiments, including various combinations of the above example embodiments, the robotic device includes an electric motor configured to impart movement to the percutaneous device in response to the motor control signal, a driver interface configured to send the user control signal to the controller in response to manipulation of the driver interface by the user, and a controller coupled to the electric motor and the driver interface. In some such example embodiments, the controller is configured to determine a clinical drive scenario associated with the robotic device, wherein the clinical drive scenario includes a distance that the percutaneous device is inserted into the patient, set a drive characteristic of the robotic device based on the clinical drive scenario and information included in a drive profile, wherein the information included in the drive profile includes information associating a particular clinical drive scenario with a particular drive characteristic, and generate the motor control signal based on the drive characteristic.

[0015] In some such example embodiments, the electric motor is further configured to impart the movement to the percutaneous device by moving a tube housing coupled to the electric motor along a drive axis in response to the motor control signal, wherein movement of the tube housing moves the percutaneous device.

[0016] In some example embodiments, the controller includes means for determining a distance that the transcutaneous device is inserted into the patient, receiving a user control signal from a driver interface, wherein the driver interface is configured to control movement of the transcutaneous device in response to user interaction with the driver interface, generating an adjusted user control signal based on the distance that the transcutaneous device is inserted into the patient, and sending the adjusted user control signal to a powered device configured to move the transcutaneous device in accordance with the adjusted user control signal.

[0017] Any or all of the above example embodiments, and other example embodiments disclosed herein, can be used in various combinations to dynamically manipulate movement of a transcutaneous device. BRIEF DESCRIPTION OF DRAWINGS

[0018] The example embodiments will become more fully understood from the detailed description and the accompanying drawings, wherein like elements are referred to by like reference numerals. The example embodiments are illustrated by way of example only and thus are not limiting to the present disclosure.

[0019] Figure 1 is a diagram of a system in accordance with various example embodiments;

[0020] Figure 2 is a diagram of a transcutaneous device inserted into a patient in accordance with various example embodiments;

[0021] Figure 3 is a diagram of a transcutaneous device manipulation system in accordance with various example embodiments;

[0022] Figure 4 is a diagram of a stack of transcutaneous devices in accordance with various example embodiments;

[0023] Figure 5 is a flowchart illustrating a method in accordance with various example embodiments;

[0024] Figure 6 is a flowchart illustrating a method in accordance with various example embodiments;

[0025] Figure 7 is a flowchart illustrating a method in accordance with various example embodiments;

[0026] Figure 8 is a flowchart illustrating a method in accordance with various example embodiments;

[0027] Figure 9 is a flowchart illustrating a method in accordance with various example embodiments;

[0028] Figure 10 is a flowchart illustrating a method in accordance with various example embodiments;

[0029] Figure 11is a flowchart illustrating a method according to various example embodiments;

[0030] Figure 12 is a flowchart illustrating a method according to various example embodiments;

[0031] Figure 13 is a diagram illustrating imaging system field of view (FoV) positioning in relation to table position according to various example embodiments;

[0032] Figure 14 is a diagram illustrating imaging system field of view (FoV) positioning in relation to percutaneous device manipulation system according to various example embodiments;

[0033] Figure 15 is a diagram illustrating imaging system field of view (FoV) positioning in relation to patient height and / or table position according to various example embodiments;

[0034] Figure 16 is a series of diagrams illustrating percutaneous device drive characteristics according to various example embodiments;

[0035] Figure 17A and 17B illustrates using detents to adjust control resolution of percutaneous device movement according to various example embodiments;

[0036] Figure 18 is a diagram illustrating position control clip according to various example embodiments;

[0037] Figure 19 is a diagram illustrating clip velocity control signal according to various example embodiments;

[0038] Figure 20 is a block diagram of a percutaneous device control system according to various example embodiments; and

[0039] Figure 21 is a block diagram of a processing system according to various example embodiments.

[0040] It should be noted that these drawings are intended to illustrate the general characteristics of methods, structures and / or materials utilized in certain example embodiments and to supplement the written description provided below. These drawings are not, however, intended to define or limit the precise architecture or performance characteristics of any given embodiment and, as such, should not be interpreted in that manner. Similar or identical components shown in various drawings are intended to represent similar or identical elements or features. DETAILED DESCRIPTION

[0041] Various example embodiments will now be described, by way of example, with reference to the accompanying drawings, in which are shown some example embodiments.

[0042] Detailed illustrative embodiments are disclosed herein. However, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and a representative example embodiment. The example embodiments can be practiced in many alternative forms and should not be construed as limited to the embodiments set forth herein.

[0043] It should be understood that there is no intention to limit the example embodiments to the specific forms disclosed. On the contrary, the example embodiments are intended to cover all modifications, equivalents and alternatives falling within the scope of the disclosure. Like numbers refer to like elements throughout the description of the figures. One or more example embodiments described herein can be combined.

[0044] Reference is first made to Figure 1 System 110 will be discussed in accordance with various example embodiments. In the illustrated example embodiment, system 110 includes a bedside system 112 for automatically performing a percutaneous interventional procedure under the control of a medical professional.

[0045] As Figure 1 shown, patient 111 is supported on a table 114. The medical professional can observe the procedure using an imaging device 113 (e.g., a fluoroscopic X-ray device) included in bedside system 112. A cassette 122, supported by a robotic arm 120, can be used to automatically feed a guide wire 250 (as Figure 2 shown) into a guide catheter 140 in patient 111. Cassette 122 can be controlled from a remote station 124 in order to isolate medical personnel performing the procedure from X-ray radiation exposure used to monitor the procedure by using the fluoroscopic device. In various example embodiments, remote station 124 includes a remote control 126 for controlling cassette 122 and a screen 128 for monitoring progress of the procedure. In the illustrated example embodiment, screen 128 displays an arterial system 129 being treated by the procedure.

[0046] Reference is next made to Figure 2Placement of a percutaneous device within a patient 111 will be discussed in accordance with various example embodiments. As shown, a guide catheter 140 has been advanced into a torso 230 of a patient 111 to reach a heart region 232. Within the guide catheter 140 is a guidewire 250, the tip 252 of which has not yet exited the distal end 242 of the guide catheter 140. An imaging device 113 can be used to monitor the progress of the guidewire 250 as it is threaded through the guide catheter 140 and approaches the distal end 242 thereof. In some example embodiments, the field of view of the imaging device 113 can be zoomed as one or more device tips approach the region of interest 252. The imaging device 113 can also be instructed to capture images at a more frequent rate once the tip 252 enters the region of interest 232.

[0047] Figure 3 A diagram of a percutaneous device manipulation system 300 will be discussed in accordance with various example embodiments. The percutaneous device manipulation system 300 includes a plurality of tube / housing 310 that are connected to a guide catheter 140 having an introducer sheath at a distal end. As the tube / housing 310 are moved along and / or rotated relative to a drive shaft 351, the tube / housing 310 connected to the guide catheter 140 can be used to impart movement to the guide catheter 140. Other tube / housing 310 can be connected to a working catheter placed within the guide catheter 140 (not shown), a pediatric guide catheter, etc., such that each tube / housing 310 can impart linear and / or rotational movement to a different catheter / subcutaneous device. Additional discussion regarding the operation of the percutaneous device manipulation system 300 is provided subsequently in the discussion of Figure 20 and 21 .

[0048] In at least one example embodiment, kinematic information regarding the position of the tube / cassette 310 relative to their starting position can be obtained from sensors included in the percutaneous device handling system 300 and in many cases belonging to each individual tube / cassette 310. For example, a linear encoder can be used to determine the linear distance traveled by the tube / cassette 310. The linear encoder can include, for example, an optical and / or mechanical reader that determines the linear distance traveled by monitoring a plurality of markers, slots, or otherwise by detecting the position of the tube / cassette 310 relative to a scale that the sensor passes over. Worm gears, sprockets, and the like can be used to determine linear and / or rotational position, which can be used in some example embodiments of the tube / cassette 310. In some such example embodiments, a rotational sensor can be used to monitor the number of revolutions of a gear or sprocket, and this information can be used to determine the amount of displacement along the drive shaft 351. The rotational rate and / or changes in rotational rate of the percutaneous device can also be measured or calculated to determine velocity, acceleration, angular velocity, angular acceleration, direction of movement, and the like. In various example embodiments, other sensors can be used, such as optical sensors employing a through-beam, mirror or diffuse reflection techniques, as well as other mechanical or electronic sensors. In various example embodiments, the kinematic information is sent to a controller, which can use the information to determine the distance that the percutaneous device is inserted into the patient.

[0049] Referring next to Figure 4 Percutaneous device stacks 400 and 450 will be briefly discussed in accordance with various example embodiments. In various example embodiments, multiple percutaneous devices can be combined or stacked depending on the procedure being performed. The types of devices used for a particular procedure are beyond the scope of this disclosure. However, in some example embodiments, the number of stacked devices, the types of stacked devices, and the type of procedure being performed affect the desired drive characteristics of the percutaneous device, are factors used in determining the clinical drive scenario associated with particular percutaneous device drive characteristics.

[0050] In the illustrated example embodiment, the first device stack 400 includes two stacked percutaneous devices, a guide catheter 441 and a working catheter 442. Each of the guide catheter 441 and the working catheter 442 is connected to a separate Y-connector 410. An insertion guide 403 and a guide wire 451 are also included in the first device stack 400. One end of the guide catheter 441 is connected to the Y-connector 410, one end of the working catheter 442 is connected to a second Y-connector 410, and the other end is located inside the guide catheter 441. The guide wire 451 is located inside the working catheter 442, and thus also inside the guide catheter 441. In various example embodiments, the first device stack can be locked into one or more tube / cassettes 310.

[0051] In the illustrated example embodiment, the second device stack 450 includes three stacked percutaneous devices, a guide catheter 443 and a mother catheter 444 and a daughter catheter 445. As with the first device stack 400, each catheter is connected to the Y-connector 410, and each catheter is "nested" with an adjacent catheter. The percutaneous devices included in the second device stack 450 can be different than the percutaneous devices included in the first device stack 400.

[0052] In at least some example embodiments, a medical professional can input the type and number of percutaneous devices included in the device stack selected for use, and this information can be used as an input to the controller, which is configured to determine a clinical drive scenario associated with percutaneous device drive characteristics. In some example embodiments, the information can be input via direct user input, scanning a barcode or QR code using a scanning device, using a device SKU to reference an internal database for parameters such as device length, inner diameter / outer diameter (ID / OD), device class / category, etc.

[0053] In at least one example embodiment, a single clinical drive scenario can be associated with an entire stack, but the drive characteristics associated with individual percutaneous devices included in the stack can be different. Some considerations for selecting a clinical drive scenario for a stack can include, but are not limited to, the information included in Table 1. Table 1

[0054] In some example embodiments, a percutaneous device can be allowed to travel at a higher speed when the device or device stack is in a safe loading position, such as when the percutaneous device is fully within another device, fully protected and not exposed in the anatomy.

[0055] Reference will be made to Figures 5-12 Methods according to various example embodiments are discussed. Reference is made to Figures 5-12 Any or all of the methods discussed can be performed by a controller, such as is subsequently referenced Figure 21 The controller 1940 shown and discussed, or some other suitable processing device and / or system.

[0056] Reference is next made to Figure 5Method 500 will be discussed in terms of various example embodiments. As shown in method 500, a clinical drive scenario can be determined at block 510. In various example embodiments, the clinical drive scenario can be determined based at least in part on kinematic information obtained from the percutaneous device manipulation system, kinematic information obtained from the movable table, a patient position, a size of the patient, an estimated or measured length of a blood vessel of the patient, a number and type of devices in the stack, a field of view (FoV) of the imaging system, a position of the imaging system (or some portion of the imaging system), a distance that the percutaneous device has traveled into the patient, whether the device stack is in a safe loading position, a portion of the body in which the percutaneous device is or will be located, some combination of the above information.

[0057] In at least some example embodiments, one or more drive profiles can be suggested, and a medical professional executing the process can select a drive scenario from the provided choices. In some example embodiments, the drive profiles can be user-customizable. In various example embodiments, the controller can automatically adjust the drive scenario without requiring manual input from an operator, with a potential emergency manual override available in some example embodiments.

[0058] As shown in block 550, drive characteristics of the percutaneous device can be set or changed based on the clinical drive scenario. In various example embodiments, one or more drive profiles are stored in a memory accessible by a controller of the percutaneous device manipulation system 300( Figure 3 ). The controller and / or the memory can be part of the percutaneous device manipulation system 300, part of a computing device (such as a remote station 124 Figure 1 ) for accepting drive input from a medical professional operating the percutaneous device manipulation system 300, or in another suitable location. Reference is made to Figure 20 and 21 The controller according to various example embodiments is discussed further below.

[0059] In at least one example embodiment, the drive profiles can be stored in one or more memories, such as memory 2192 Figure 21 ). Some portions of the drive profiles can be stored on remote computing devices accessible via a communications network, such as in a cloud-based storage server, in a memory included in the bedside system 112, in the remote station 124, or elsewhere. The drive profiles can be stored in data structures known to those of ordinary skill in the art, including but not limited to in a relational database, a lookup table, a tree, an array, a heap, and the like. In various example embodiments, the drive profiles include information linking one or more drive scenarios to particular drive characteristics.

[0060] For example, a first drive scenario can specify that a first type of percutaneous device inserted 50 cm into a 6 foot tall patient can have a first maximum allowable linear velocity, be prohibited from rotating, have a first maximum acceleration, and have a control signal multiplier of 1. In some example embodiments, the control signal multiplier can be a factor by which an input signal from the driver is multiplied to generate a correction signal.

[0061] Continuing with the same example, a second drive scenario can specify that the same percutaneous device inserted 150 cm into the same 6 foot tall patient has a reduced maximum allowable linear velocity, is allowed to rotate up to 30 degrees in either direction, has a reduced maximum acceleration, and has a control signal multiplier of 0.6. By reducing the control signal multiplier, an input signal of, for example, 1 mV generated by the drive input device will be "smoothly" reduced to 0.6 mV. In other example embodiments, as discussed later herein, the raw control signal can be clipped rather than multiplied. As used herein, clipping a signal includes, but is not limited to, limiting the maximum instantaneous and / or average voltage or current of the signal to a maximum level. Clipping can include, for example, limiting the peak and / or root mean square voltage of a sinusoidal or other varying waveform by shunting a portion of the signal to ground using diodes or other clipping circuitry. Various techniques for clipping digitized waveforms and / or unvarying waveforms are also known in the art. For example, the duty cycle of a digital waveform can be limited, effectively clipping the average voltage of the control signal.

[0062] In some such example embodiments, the drive profile links the selected drive scenario to drive characteristics and automatically sets or adjusts the drive characteristics associated with the percutaneous device until a new drive scenario is selected.

[0063] Referring next to Figure 6 Method 600 will be discussed in accordance with various example embodiments. In the illustrated example embodiments, blocks 610, 620, and 630 are subtasks of block 510, and blocks 640, 650, and 660 are subtasks of block 550. As shown in block 610, a position of the patient can be determined. In various example embodiments, the position of the patient can be determined based on kinematic information from the moveable table, based on an imaging system, based on the size / height of the patient, etc.

[0064] As shown in block 620, in accordance with some example embodiments, position information indicative of the position of the subcutaneous device relative to the patient is obtained. This information can be obtained based on the position of percutaneous device manipulation system 300 relative to the patient position, in combination with the distance that the tube housing has moved along the drive shaft of percutaneous device manipulation system 300, based on information obtained from an imaging system, etc.

[0065] As represented by block 630, a clinical drive scenario is determined based on the results of block 620. For example, in some example embodiments, there can be three drive scenarios. It should be appreciated that there can be substantially more than three potential drive scenarios, but for ease of illustration, three are selected. A first drive scenario can be used when the percutaneous device is between approximately 0 cm and 40 cm in the patient, a second drive scenario can be used when the percutaneous device is between approximately 40 cm and 70 cm in the patient, and a third drive scenario can be used when the percutaneous device is between approximately 70 cm and 90 cm in the patient. In this case, if the percutaneous device is at 10 cm in the patient, the second drive scenario would be used. It should be appreciated that in at least some example embodiments, a catheter of approximately 165 cm can be used, but the entire length of the catheter can not be inserted into the patient. The above discussion is provided to provide one example and is not intended to limit the different drive scenarios to only the ranges stated.

[0066] As represented by block 640, a drive profile is selected based on the clinical drive scenario. Continuing with the previous example, a plurality of drive profiles are available, with each drive profile being associated with one or more drive scenarios. Note that in some embodiments, there is not a one-to-one correspondence between drive scenarios and drive profiles. For example, a single drive profile can be associated with multiple drive scenarios, but each drive scenario can be associated with only a single drive profile. For example, there can be two drive scenarios that allow for the same maximum speed and acceleration, so the two drive scenarios can be associated with a single drive profile. However, in at least one example embodiment, a single drive profile will not allow for two different maximum speeds (at least for the same device).

[0067] As represented by block 650, the controller can set the drive characteristics specified in the drive profile. Because the drive profile is selected based on the drive scenario, the drive characteristics can be said to be based on the drive scenario - in some example embodiments, the drive scenario ultimately dictates the drive characteristics.

[0068] As represented by block 660, movement of the percutaneous device / percutaneous powered device can be controlled / restricted based on the drive characteristics indicated by the selected drive profile.

[0069] Reference is next made to Figure 7 Method 700 will be discussed in accordance with various example embodiments. As represented by block 710, an imaging system (such as imaging device 113 Figure 1the imaging system's FoV and indirectly from the imaging system's positioning relative to a table on which the patient is located. In some example embodiments, the controller responsible for setting the imaging system's FoV can provide information to the controller responsible for determining the clinically driven scenario. In some example embodiments, the imaging system controller and the controller responsible for determining the clinically driven scenario are the same controller.

[0070] As represented by block 720, a clinically driven scenario is determined based on the imaging system's FoV. For example, if the imaging system's FoV is greater than about 70 cm, a first drive scenario corresponding to a drive profile that allows for faster lateral movement can be selected. If the imaging system's FoV is less than 10 cm, a second drive scenario corresponding to a drive profile that limits lateral movement speed can be selected.

[0071] As represented by block 730, a drive profile is selected based on the clinically driven scenario. In various example embodiments, a table or database can be used to link the clinically driven scenario to a drive profile. In various example embodiments, as represented by block 740, drive characteristics are set based on the drive profile, and movement of the percutaneous device is controlled based on the drive characteristics, as represented by block 750.

[0072] Referring next to Figure 8 Method 800 will be discussed in accordance with various example embodiments. As represented by block 810, kinematic information indicative of a distance that a subcutaneous device has been inserted into a patient is obtained. The kinematic information includes, but is not limited to, information about a position of a movable table, information indicative of a position of a tube housing along a movement axis, position information associated with an imaging system, and the like. As represented by block 820, a clinically driven scenario is determined based on the kinematic information, and a drive profile is selected based on the clinically driven scenario, as represented by block 830. As represented by block 840, drive characteristics are selected based on the drive profile, and movement of the percutaneous device is controlled based on the drive characteristics, as represented by block 850.

[0073] Referring next to Figure 9 Method 900 will be discussed in accordance with various example embodiments. As represented by block 910, a displacement of a tube housing along a drive axis of a percutaneous device manipulation system is determined. As represented by block 920, a clinically driven scenario is determined based on the displacement of the tube housing. As represented by block 930, a drive profile is selected based on the clinically driven scenario. At block 940, drive characteristics are set based on the drive profile, and movement of the percutaneous device is controlled based on the drive characteristics, as represented by block 950.

[0074] Referring next toFigure 10 Method 1000 will be discussed in accordance with various example embodiments. As shown in block 1010, a clinical scenario / drive profile is selected. The selection of the clinical drive profile can be performed using any of the various techniques or combinations of techniques disclosed in connection with the example embodiments described above. In some example embodiments, the selection of the clinical drive scenario and the selection of the drive profile constitute a single step action, such that the selection of the clinical drive scenario is coextensive with the selection of the drive profile.

[0075] As shown in block 1020, the controller receives movement control signals, e.g., drive control signals, from the medical professional interacting with the drive interface. As shown in block 1030, the controller adjusts the received control signals and generates adjusted control signals based on the clinical scenario / drive profile and its associated drive characteristics. As discussed elsewhere herein, in various example embodiments, the adjusted control signals can be clipped, applied with a negative or positive gain, filtered, blocked, or otherwise modified digitally or in an analog manner. For example, if a maximum speed has been reached, a user requested "speed increase" signal can be immediately clipped. In another example embodiment, if the percutaneous device is accelerating too quickly, but has not yet reached a maximum speed, a user requested "speed increase" signal can be "muted" or applied with a negative gain to allow acceleration, but at a reduced rate.

[0076] As shown in block 1040, the adjusted / modified control signals can be sent to the powered device in place of the original control signals. Reference is made to Figure 20 and 21 Additional discussion of control signals and various powered devices is provided.

[0077] Reference is next made to Figure 11 Method 1100 will be discussed in accordance with various example embodiments. As shown in block 1105, a position of a patient is determined. As shown in block 1110, a position of an imaging system relative to the patient is determined. In some example embodiments, determining the position of the imaging system includes, but is not limited to, determining a position of an arm of the imaging system.

[0078] As shown in block 1115, a clinical drive scenario is determined based on the position of the imaging system, e.g., the arm of the imaging system. As shown in block 1120, a drive profile is selected based on the drive scenario. As shown in block 1125, drive characteristics of a percutaneous device are set based on the clinical drive profile. As shown in block 1130, the percutaneous device is moved or limited in movement based on the drive characteristics.

[0079] As represented by block 1135, the position of the imaging system is monitored to determine whether the imaging system has moved. If the imaging system has moved, as represented by block 1140, a check is made to determine whether the new position of the imaging system requires a new drive scenario, or whether the new position still indicates use of the current clinical drive scenario.

[0080] As represented by block 1145, if the new position of the imaging system is not within the current clinical drive scenario, a new clinical drive scenario is selected, and at block 1150, a new drive profile is selected based on the new clinical drive scenario. As represented by block 1155, new drive characteristics of the percutaneous device are set based on the new drive profile.

[0081] Referring next to Figure 12 Method 1200 will be discussed in accordance with various example embodiments. As represented by block 1205, a length of a blood vessel of a patient is determined. In some example embodiments, the length of the blood vessel can be estimated based on a physical characteristic of the patient, such as height. In other example embodiments, imaging can be used to determine the length of the blood vessel of the patient.

[0082] As represented by block 1210, a position of the patient is determined. In various example embodiments, the position of the patient can be determined based on, but need not be based on, placement of the patient on a table.

[0083] As represented by block 1215, a desired insertion point of a percutaneous device is determined based on the length of the blood vessel of the patient.

[0084] As represented by block 1220, position information indicates a position of the percutaneous device. This position information can be obtained, for example, from sensors included in the percutaneous device manipulation system 300.

[0085] As represented by block 1225, the controller determines whether the percutaneous device has exceeded a threshold distance from the insertion point. If the percutaneous device has not exceeded the threshold distance from the insertion point, the method 1200 returns to block 1220 and additional position information is monitored.

[0086] As represented by block 1235, if the percutaneous device has traveled further from the insertion point than the threshold distance, a clinical drive scenario is selected.

[0087] As represented by block 1240, a determination is made as to whether the position information indicates that the percutaneous device has been inserted into the patient to within a threshold distance of the desired insertion point. In at least one example embodiment, the determination is made based at least in part on a distance the percutaneous device has traveled and the length of the blood vessel of the patient. In various example embodiments, verification can be performed using an imaging system.

[0088] As represented by block 1245, if the percutaneous device has been inserted into the patient to within a threshold distance of the desired insertion point, a new clinical drive scenario is selected.

[0089] Referring next Figure 13 Imaging system field of view (FoV) positioning in relation to table position will be discussed in accordance with various example embodiments. In the illustrated example embodiment, table 114 can be moved vertically and / or horizontally relative to table base 1355 to allow positioning of patient 111.

[0090] In some example embodiments, the imaging system can include a C-arm for positioning the imaging system over a particular region of the patient, and positioning of the C-arm can determine the size of the FoV of the imaging system. For example, in a first position 1310, the FoV 1340 when the imaging system is positioned near the patient’s head can be narrower than the FoV 1350 when the imaging system is positioned over the patient’s torso in a second position 1320. In other example embodiments, the physician can be able to reduce the FoV by instructing the imaging system to zoom in. In at least some example embodiments, when the FoV is narrower, a clinically driven scenario can be selected to allow slower / fine-tuned control. In some such embodiments, the determination of the FoV can be achieved through C-arm pose information, imaging software parameters, and / or table kinematics data.

[0091] Referring next Figure 14 Imaging system field of view (FoV) positioning in relation to percutaneous device steering system will be discussed in accordance with various example embodiments. In various example embodiments, the imaging system FoV can be based on the positioning of the imaging device relative to the table position and / or the positioning of the percutaneous device steering system 300 at the introducer site. In some such example embodiments, zoom regions with different FOVs can be based on the positioning of the imaging system relative to the table position and / or the positioning of the percutaneous device steering system 300.

[0092] In the illustrated example embodiment, the region 1414 extending from the patient’s head to the end of the percutaneous device steering system 300 can be divided into three regions 1403, 1405, and 1407 of unequal size, which have different FOVs.

[0093] Referring next Figure 15 Imaging system field of view (FoV) positioning in relation to patient height and / or table position will be discussed in accordance with various example embodiments. In various example embodiments, the imaging system FoV can be based on the positioning of the imaging device relative to the table position and / or the patient height.

[0094] In the illustrated example embodiment, the region 1514 extending from the patient’s head to the patient’s feet can be divided into three regions 1503, 1505, and 1507 of unequal size, which have different FOVs.

[0095] In other example embodiments, the distance that the percutaneous device has been inserted and thus the adjustment of the FOV and / or the selection of the clinical driven scenario can be determined through the use of image-based sensor patient markers and / or 3D scan data, the use of fluorescent image recognition to determine anatomical markers and device tip location, the use of opaque markers, or various combinations thereof.

[0096] Referring next to Figure 16 A graph 1600 of percutaneous device driven characteristics will be discussed in accordance with various example embodiments. The graph 1600 shows various driven characteristics associated with a particular driven scenario / driven profile. In each graph, time moves from left to right. The top graph shows a distance graph 1605, representing the distance that the percutaneous device has traveled.

[0097] The middle graph shows a velocity graph 1610. Considering the distance graph 1605 and the velocity graph 1610, it will be noted that the percutaneous device moves forward continuously during phase 1, phase 2, and phase 3. It will also be noted that as the device moves forward, the velocity increases during phase 1 until a peak velocity 1612 is reached during phase 2, and the velocity of the device decreases during phase 3.

[0098] Adding the following graph, which shows an acceleration graph 1621 that appears discontinuous, it will be noted that the percutaneous device is at peak acceleration during the entire phase 1, the device is at peak deceleration during the entire phase 3, and there is no acceleration or deceleration during phase 2. The graph 1621 exhibits a high degree of "jerk."

[0099] The maximum of any or all of these characteristics can be set by the driven profile associated with the driven scenario, and appropriately controlled by the controller that modifies the user control / driven signal. For example, the jerk can be smoothed using a damping or filtering function, and the peak velocity can be clipped. In some example embodiments, the maximum acceleration can be limited by gradually attenuating the user signal that increases the velocity.

[0100] Figure 18 And 19 An example is shown of how changing the peak velocity during position control can result in signal clipping. In various example embodiments, limiting the peak velocity results in finer control because shorter displacements occur in the same amount of commanded time. In some example embodiments, the velocity of the input position command signal is clipped / limited to 1 turn per second.

[0101] In some example embodiments, percutaneous device position control can be implemented as a rotary dial or other scrolling device that can measure driver control input based on scrolling displacement (e.g., number of resolutions, angle of rotation, etc.). A physician can control the displacement of the percutaneous device by manipulating the percutaneous device position. In some example embodiments, a per-input displacement ratio of 1 scroll = mm can be used. In at least one example embodiment, the absolute displacement allowed can be set to, for example, 3 turns.

[0102] Figure 17A and 17B shows using detents to adjust the control resolution of percutaneous device movement. In some such example embodiments, the resolution or scale angle per scroll of the scrolling device 1781 can change based on the position of the percutaneous device. For example: for finer control, the detents of the scrolling device 1781 can be set to 1 mm of percutaneous device movement per count of 20 turns, while for coarser control, set to 1 mm of percutaneous device movement per count of 50 turns. Increased scrolling angle allows for finer degree to mm of movement ratios, enabling more precise control. The scrolling torque represents the "detent" or resistance feel when rotating the scroll wheel.

[0103] As Figure 17A shown, in the case where the detents of the scrolling device 1781 are set to a count of 50 turns (process control), the percutaneous device moves linearly 1 mm in response to the scrolling device 1781 rotating a scrolling angle 1703 of 7.2 degrees in Figure 17A Note that the numbers shown on the scrolling device 1781 can not be marked on the scrolling device 1781, but are illustrated to show the number of counts per turn. The scrolling torque 1701 can start to increase just before each detent corresponding to 7.2 degrees, and reach its maximum value at each detent. In some example embodiments, the maximum scrolling torque 1701 value at the detent peak can be in the range of 10-20 mNm, although this value can depend on the diameter of the scroll wheel or other scrolling mechanism. In some example embodiments, as the scrolling angle 1703 continues to increase beyond the detent, which in the illustrated example embodiment is 7.2 degrees, the scrolling torque 1701 starts to decrease, and reaches a substantially flat level, which can be less than 1 mNm of resistance, to allow the scroll wheel to rotate with minimal resistance until near the next detent - at which point the scrolling torque starts to increase again. In contrast, as Figure 17B shown for fine control, the detents can be set at a frequency of 20 counts per turn, where the detents are set such that the scrolling torque 1701 increases at each 18 degree scrolling angle 1703.

[0104] Changing the detents can be based on the drive profile from the controller (e.g., controller 2040 Figure 20control signals and / or based on the position of the percutaneous device. In at least one example embodiment, a haptic knob or other device known to those of ordinary skill in the art can be used to adjust the roll torque 1701 in response to the control signals.

[0105] Referring to Figure 18 A graph 1800 showing position control clipping will be discussed in accordance with various example embodiments. The graph 1800 includes a position input command graph 1810, which represents signals from drive inputs generated in response to a physician's interaction with a drive interface. A clipped input 1820 represents modified control signals generated by a controller and sent to a powered device (e.g., an advance / retreat actuator 2072 or 2076 Figure 20 )) of the powered device.

[0106] Referring to Figure 19 A graph 1900 showing clipped velocity control signals will be discussed in accordance with various example embodiments. The graph 1900 includes an input velocity graph 1910, which represents signals from drive inputs generated in response to a physician's interaction with a drive interface. A clipped input 1920 represents modified control signals generated by a controller and sent to a powered device (e.g., an advance / retreat actuator 2072 or 2076 Figure 20 )) of the powered device.

[0107] In some example embodiments, device-specific characteristics can be included in a drive profile / drive scenario. For example, a drive profile / drive scenario can include a rotation lock for devices that are specified not to rotate, such as a stent retriever, a balloon catheter, etc. In some example embodiments, a force limit can be included as a drive characteristic. When a certain device is selected and installed in a module, the force limit can be used to change the maximum force that the module will exert. Further, a drive characteristic can include a linear displacement limit for devices that require relative movement between two components, such as a carotid stent.

[0108] Referring next to Figure 20A percutaneous device control system 2000 will be discussed in accordance with various example embodiments. Various embodiments of percutaneous device control systems are described in P.C.T. International Application No. PCT / US2021 / 070042, filed November 14, 2021, P.C.T. International Application No. PCT / US2020 / 041964, filed July 7, 2020, P.C.T. International Application No. PCT / US2009 / 042720, filed May 4, 2009, P.C.T. International Application No. PCT / US2020 / 041923, filed July 14, 2020, U.S. Patent No. 8,480,618, issued July 9, 2013, the entire contents of each of the foregoing applications are incorporated herein by reference. The percutaneous device control system 2000 can include a bedside system 112 that includes various actuation mechanisms that move associated percutaneous devices in response to user manipulation of controls 2081. In at least one example embodiment, the controls can include rotary inputs, such as haptic knobs 1781. In the illustrated example embodiment, the bedside system 112 includes a guidewire actuation mechanism 2050, a working catheter actuation mechanism 2052, and a guide catheter actuation mechanism 2054. In other example embodiments, the bedside system 112 can include actuation mechanisms for inflating angioplasty or stent delivery balloons and for delivering contrast media. In the illustrated example embodiment, the guidewire actuation mechanism 2050 and the working catheter actuation mechanism 2052 are contained within a cartridge housing 2056.

[0109] The guidewire actuation mechanism 2050 is coupled to the guidewire 2058 such that the guidewire actuation mechanism 2050 is able to advance, retract, and rotate the guidewire 2058. In various example embodiments, the working catheter actuation mechanism 2052 is coupled to the working catheter 2060 such that the working catheter actuation mechanism 2052 is able to advance, retract, and rotate the working catheter 2060. The guide catheter 2064 is coupled to the guide catheter actuation mechanism 2054 such that the guide catheter actuation mechanism 2054 is able to advance, retract, and rotate the guide catheter 2064. In various example embodiments, the guidewire actuation mechanism 2050, the working catheter actuation mechanism 2052, and the guide catheter actuation mechanism 2054 can each include engagement structures adapted to engage respective percutaneous devices such that the actuation mechanisms are able to impart axial and / or rotational movement to the percutaneous devices.

[0110] Y-connector 2066 can be coupled to guide catheter actuation mechanism 2054 via connector 2068. In the example embodiment shown, Y-connector 2066 is connected to cartridge housing 2056. In some example embodiments, Y-connector 2066 includes a first leg, a second leg, and a third leg. The first leg of Y-connector 2066 can be connected to, or in communication with, the lumen of guide catheter 2064. The second leg can be angled away from the longitudinal axis of guide catheter 2064 and provide a port for injecting fluid (e.g., contrast, medication, etc.) into the lumen of guide catheter 2064. The third leg of Y-connector 2066 is coupled to cartridge housing 2056 and receives both guide wire 2058 and working catheter 2060. With this arrangement, guide wire 2058 and working catheter 2060 are inserted into the lumen of guide catheter 2064 through Y-connector 2066. A hemostatic valve and Y-connector useful with the present application is shown in US 9,452,277, which is incorporated by reference herein in its entirety.

[0111] In the example embodiment shown, guide wire actuation mechanism 2050 includes a rotation actuator 2070 and an advance / retract actuator 2072. Rotation actuator 2070 can be configured to cause guide wire 2058 to rotate about its longitudinal axis. Advance / retract actuator 2072 can be configured to advance and / or retract guide wire 2058 within patient 111 (i.e., advance and / or retract along the longitudinal axis of the guide wire). Working catheter actuation mechanism 2052 includes a rotation actuator 2074 and an advance / retract actuator 2076. Rotation actuator 2074 is configured to cause working catheter 2060 to rotate about its longitudinal axis. Advance / retract actuator 2076 is configured to advance and / or retract working catheter 2060 within patient 111 (e.g., advance and / or retract along the longitudinal axis of the working catheter).

[0112] In various example embodiments, guide catheter actuation mechanism 2054 includes a rotation actuator 2078, an advance / retract actuator 2080, and a bend actuator 2082. Rotation actuator 2078 is configured to cause guide catheter 2064 to rotate about its longitudinal axis. Advance / retract actuator 2080 is configured to advance and / or retract guide catheter 2064 within patient 111 (e.g., advance and / or retract along the longitudinal axis of the guide catheter).

[0113] In some embodiments, guide catheter 2064 can include one or more bend control elements that allow a user to cause the distal end of guide catheter 2064 to bend. In such embodiments, bend actuator 2082 can cause the distal end of guide catheter 2064 to bend in response to manipulation of control 2081 by a user. An example of one bend control element that can be used with the present application is shown in US 2024 / 0024055, which is incorporated by reference herein in its entirety.

[0114] In various example embodiments, controls 2081 at workstation 2014 and controller 2040 are communicably coupled to various portions of bedside system 112 to allow a user to control movement of guidewire 2058, working catheter 2060, and guide catheter 2064, as well as any other percutaneous devices included in bedside system 112. In some example embodiments, in addition to or in place of controller 2040 at workstation 2014, an optional controller 1240a can be included in bedside system 112 or located at another location external to workstation 2014. In at least one example embodiment, optional controller 1240a has the same functionality as described for controller 2040.

[0115] In the illustrated example embodiment, controls 2081 and controller 2040 are coupled to guide catheter actuation mechanism 2054 to allow a user to move guide catheter 2064. In addition, controls 2081 are coupled to cartridge housing 2056 to allow a user to control guidewire 2058 via guidewire actuation mechanism 2050 and to control working catheter 2060 via working catheter actuation mechanism 2052.

[0116] In some example embodiments, cartridge housing 2056 is configured to be coupled to a motorized base. In this embodiment, each actuator 2070, 2072, 2074, and 2076 of cartridge housing 2056 is configured to engage a capstan that extends from the motorized base. A motor located within the motorized base drives (e.g., rotates) the capstan, which in turn drives actuator 2070, 2072, 2074, and 2076 of cartridge housing 2056. When actuator 2070, 2072, 2074, and 2076 of cartridge housing 2056 is engaged with guidewire 2058 and working catheter 2060, respectively, actuator 2070, 2072, 2074, and 2076 of cartridge housing 2056 imparts rotational movement of the capstan to cause movement of guidewire 2058 and working catheter 2060. In another embodiment, the motor that drives the capstan of the motorized base can be located external to the base, which is connected to cartridge housing 2056 via suitable transmission devices (e.g., shafts, cables, etc.). In yet another embodiment, cartridge housing 2056 includes a motor associated with actuator 2070, 2072, 2074, and 2076 located within cartridge housing 2056, and cartridge housing 2056 is mounted to a base that provides power (e.g., a battery, AC building power, etc.) to the motor within cartridge housing 2056.

[0117] Reference Figure 21A processing system 2040 will be discussed in accordance with various example embodiments. The processing system 2040 can be an electronic control unit configured to provide the various functionality described herein to the transcutaneous device control system 2000. For example, the processing system 2040 can be an embedded system, a special-purpose circuit, a general-purpose system programmed with the functionality described herein, etc. The processing system 2040 includes a processing circuit 2190, a memory 2192, a communication module or subsystem 2194, a communication interface 2196, a process control module or subsystem 2198, an analog module or subsystem 2103, an auxiliary control module or subsystem 2102, a mode selection module or subsystem 2104, an inventory module or subsystem 2106, a GUI module or subsystem 2108, a data storage module or subsystem 2110, and a logging module or subsystem 2112.

[0118] The processing circuit 2190 can be a general-purpose processor, a special-purpose processor (ASIC), a circuit including one or more processing components, a group of distributed processing components, a group of distributed computers configured for processing, etc., configured to provide the functionality of the module or subsystem components. The memory 2192 (e.g., memory units, memory devices, storage devices, etc.) can be one or more devices for storing data and / or computer code for completing and / or facilitating the various processes described in the present disclosure.

[0119] The memory 2192 can include volatile memory and / or non-volatile memory. The memory 2192 can include database components, object code components, script components, and / or any other type of information structures for supporting the various activities described in the example embodiments. According to an example embodiment, any combination of distributed and / or local memory devices can be utilized with systems and methods of the present disclosure. According to an example embodiment, the memory 2192 is communicably connected to the processing circuit 2190 and the module components (e.g., via a circuit or any other wired, wireless, or network connection) and includes computer code for implementing one or more processes described herein. A single memory unit can include various individual memory devices, chips, disks, and / or other storage structures or systems.

[0120] Any or all of the module or subsystem components can include computer code (e.g., object code, program code, compiled code, script code, executable code, or any combination thereof), hardware, software, or any combination thereof for implementing the respective functions of each module. One or more portions of any or all of the module components can be stored in the memory 2192 or in one or more local, distributed, and / or remote memory units communicably connected to the processing circuit 2190 or another suitable processing system.

[0121] In various example embodiments, the communication interface 2196 includes one or more components for communicatively coupling the processing system 2040 to other components of the transcutaneous device control system 2000 via a communication link. The communication interface 2196 can include one or more jacks or other hardware for physically coupling the communication link to the processing system 2040, analog-to-digital converters, digital-to-analog converters, signal processing circuitry, and / or other suitable components. The communication interface 2196 can include hardware configured to connect the processing system 2040 with other components of the transcutaneous device control system 2000 via a wired or wireless connection. The communication module 2194 is configured to support communication activities of the processing system 2040 (e.g., negotiating a connection, communicating via a standard or proprietary protocol, etc.).

[0122] The data storage module 110 is configured to support storage and retrieval of information by the processing system 2040. In one or more example embodiments, the data storage module 2110 is a database for storing patient-specific data, including image data. In another embodiment, the data storage module 2110 can be located on a hospital network. The data storage module 2110 and / or the communication module 2194 can also be configured to import and / or export patient-specific data from the hospital network for use by the processing system 2040.

[0123] In various example embodiments, the processing system 2040 also includes a procedure control module 2198 configured to support control of the bedside system 112 during a catheter-based medical procedure. The procedure control module 2198 allows a user to operate the bedside system 112 by manipulating the controls 2081. In various embodiments, the procedure control module 2198 is configured to generate one or more control signals 2016 based on the user's manipulation of the controls 2081 and / or other data available to the procedure control module 2198. In some example embodiments, the control module 2198 can alter, suppress, clip, or otherwise modify the signals received from the controls 2081 to generate the control signals 2016.

[0124] As Figure 20As shown, control signals 2016 generated by the procedure control module 2198 are communicated from the processing system 2040 to various actuators of the bedside system 112. In response to the control signals 2016, the actuators of the cassette housing 2056 cause movement of the guidewire, working catheter, and / or guide catheter. The procedure control module 2198 can also cause data appropriate to the particular procedure to be displayed on a monitor. The procedure control module 2198 can also cause various icons to be displayed on the touchscreen with which a user can interact to control use of the bedside system 112. In some example embodiments, the procedure control module 98 is configured to cause the bedside system 112 to move (e.g., set or adjust a rate of movement or rotation) in response to particular inputs received by the controls 2081 as modified by the drive profile associated with the clinical drive scenario. In one or more example embodiments, the procedure control module 98 can be configured so that when the guidewire control 23 is actuated, the bedside system 112 causes the guidewire to advance, retract, or rotate at a rate that is determined in part by user interaction with the controls 2081 and in part by drive characteristics associated with the current clinical drive scenario.

[0125] In some example embodiments, a rate of movement of the percutaneous device caused by the bedside system 112 is proportional to an amount of displacement of the controls as modified by information included in the drive profile that associates the clinical drive scenario with particular drive characteristics. For example, where the controls 23, 25, and 29 are joystick controls, the rate of movement of the percutaneous device caused by the bedside system 112 can be a function of an extent of displacement of the joystick from a rest position.

[0126] In the example embodiment shown, the processing system 2040 includes a GUI module 2108 that controls display of various information on one or more display devices. In various example embodiments, the GUI module 2108 can be configured to display image data captured by the imaging system 12 included in the catheter procedure system 110. In one example embodiment, as shown in FIG. 21, the GUI module 2108 can be configured to cause a monitor or other display device to display an image of a portion of the patient 111 during a catheterization procedure. Figure 2 As shown, the GUI module 2108 can be configured to cause a monitor or other display device to display an image of a portion of the patient 111 during a catheterization procedure.

[0127] Non-limiting illustrative embodiments In illustrative embodiment 1, a controller includes at least one processor; a memory coupled to the at least one processor, the memory storing computer-executable instructions; and wherein the at least one processor is configured to execute the computer-executable instructions to cause the controller to determine a clinical drive scenario associated with a percutaneous device, and to set drive characteristics associated with the percutaneous device based on the clinical drive scenario and information included in a drive profile, wherein the information included in the drive profile includes information that associates a particular clinical drive scenario with particular drive characteristics.

[0128] Illustrative embodiment 2 includes the controller of embodiment 1, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine a clinical drive scenario based on a comparison of position information indicative of a distance the transcutaneous device is inserted into the patient, the distance the transcutaneous device is inserted into the patient, and the estimated length of the patient’s blood vessel, wherein the position information includes at least one of: information indicative of a position of an arm of the imaging system relative to the patient, a positioning of the transcutaneous device manipulation system relative to the patient, a position of a tube housing along a drive shaft of the transcutaneous device manipulation system, an image recognition of a marker on the patient, or an image recognition of a marker on the transcutaneous device.

[0129] Illustrative embodiment 3 includes the controller of embodiment 1 or 2, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: receive a user control signal from the drive interface, wherein the user control signal is indicative of a requested movement of the transcutaneous device controlled by the controller; and set a drive characteristic of the transcutaneous device by modifying the user control signal based on the clinical drive scenario and information included in the drive profile.

[0130] Illustrative embodiment 4 includes the controller of any of embodiments 1-3, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine the clinical drive scenario based on at least one of a field of view of the imaging system or a position of the imaging system relative to the patient, wherein the field of view of the imaging system represents an area between an entry site where the transcutaneous device is inserted into the patient and a patient’s head.

[0131] Illustrative embodiment 5 includes the controller of any of embodiments 1-4, wherein the information included in the drive profile includes: information to adjust a particular drive characteristic under a particular clinical drive scenario.

[0132] Illustrative embodiment 6 includes the controller of any of embodiments 1-5, wherein the particular clinical drive scenario includes at least one of: a type of the transcutaneous device, a configuration of the transcutaneous device, a distance the transcutaneous device is inserted into the patient, or whether a distal portion of the transcutaneous device is still entirely within an existing transcutaneous device.

[0133] Illustrative embodiment 7 includes the controller of any of embodiments 1-6, wherein the particular drive characteristic includes at least one of: a peak velocity, a peak acceleration, a jerk, a peak rotational velocity, a peak rotational acceleration, a per input displacement ratio, a maximum absolute displacement, a maximum force, a maximum linear displacement, or a rotational lock.

[0134] Illustrative embodiment 8 includes the controller of any of embodiments 1-7, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine a distance that the percutaneous device is inserted into the patient, receive a user control signal from the driver interface, wherein the driver interface is configured to control movement of the percutaneous device in response to user interaction with the driver interface, generate an adjusted user control signal based on the distance that the percutaneous device is inserted into the patient, and send the adjusted user control signal to the powered device configured to move the percutaneous device in accordance with the adjusted user control signal.

[0135] Illustrative embodiment 9 includes the controller of any of embodiment 8, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: determine the distance that the percutaneous device is inserted into the patient based on one or more of kinematic information, a position of the imaging system relative to the patient, a positioning of the percutaneous device manipulation system relative to the patient, or a displacement of the tube housing along a drive shaft of the percutaneous device manipulation system.

[0136] Illustrative embodiment 10 includes the controller of any of embodiments 8-9, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: generate the adjusted user control signal by altering the user control signal based on at least one of a field of view of the imaging system or a position of the imaging system relative to the patient, wherein the field of view of the imaging system represents an area between an entry site into the patient at which the percutaneous device is inserted into the patient and a patient head.

[0137] Illustrative embodiment 11 includes the controller of any of embodiments 8-10, wherein the at least one processor is further configured to execute the computer-executable instructions to cause the controller to: generate the adjusted user control signal based on profile information included in a drive profile, wherein the profile information included in the drive profile includes first information associating the distance that the percutaneous device is inserted into the patient with a movement characteristic of the percutaneous device.

[0138] Illustrative embodiment 12 includes the controller of any of embodiments 8-11, wherein the profile information included in the drive profile further includes: second information associating a characteristic of the percutaneous device with at least one of a safe loading position of the percutaneous device, a percutaneous device type, or a configuration of the percutaneous device.

[0139] Illustrative embodiment 13 includes the controller of any of embodiments 8-12, wherein: the movement characteristic of the percutaneous device includes at least one of a peak velocity limit, a peak acceleration limit, a jerk limit, a rotational velocity limit, an input displacement per ratio, an absolute displacement limit, a rotational lockout, a maximum force limit, or a linear displacement limit.

[0140] Illustrative embodiment 14 includes a robotic device comprising: a motor configured to apply movement to a transcutaneous device in response to motor control signals; a driver interface configured to send user control signals to a controller in response to user manipulation of the driver interface; and the controller of any of embodiments 1-13.

[0141] Illustrative embodiment 15 includes a method comprising: determining a clinical drive scenario associated with a transcutaneous device; and setting a drive characteristic associated with the transcutaneous device based on the clinical drive scenario and information included in a drive profile, wherein the information included in the drive profile comprises information associating a particular clinical drive scenario with a particular drive characteristic.

[0142] As described herein, the terms “one or more” and “at least one” can be used interchangeably. Moreover, although the terms first, second, etc. can be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. For example, a first element could be termed a second element, and, similarly, a second element could be termed a first element without departing from the scope of the present disclosure. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0143] When an element is referred to as being “connected” or “coupled” to another element, it can be directly connected or coupled to the other element or intervening elements can be present. In contrast, when an element is referred to as being “directly connected” or “directly coupled” to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.).

[0144] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises,” “comprising,” “includes,” and / or “including,” when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0145] It should also be noted that in some alternative implementations, the functions / acts described can occur out of the order described. For example, two graphsically shown in succession can in fact be executed substantially concurrently or sometimes in reverse order, depending on the functions / acts involved.

[0146] In the preceding description, specific details have been set forth to provide an overall understanding of illustrative embodiments. However, one skilled in the art will understand that the example embodiments can be practiced without some of these specific details. For example, systems can be shown in block diagram form to avoid obscuring example embodiments in unnecessary detail. In other instances, well-known processes, structures, and techniques can be shown without detail in order to avoid obscuring the example embodiments.

[0147] As discussed herein, illustrative embodiments have been described with reference to symbolic representations of operations (e.g., in the form of flowcharts, flow diagrams, data flow diagrams, structure diagrams, block diagrams, etc.) that can be implemented with computer-usable / instructed devices or other network elements and / or hardware, such as existing user devices or other network elements and / or hardware. Such existing hardware can be processing or control circuitry, such as, but not limited to, one or more processors, one or more central processing units (CPUs), one or more controllers, one or more arithmetic logic units (ALUs), one or more digital signal processors (DSPs), one or more microcomputers, one or more field programmable gate arrays (FPGAs), one or more system-on-chips (SOCs), one or more programmable logic units (PLUs), one or more microprocessors, one or more application-specific integrated circuits (ASICs), or any other device capable of responding to and executing instructions in a defined manner.

[0148] Although the flow diagrams can describe the operations as a sequential process, many of the operations can be performed in parallel, concurrently, or concurrently. In addition, the order of the operations can be rearranged. A process can be terminated when its operations are completed, but can also have additional steps not included in the figure. A process can correspond to a method, function, procedure, subroutine, subprogram, etc. When a process corresponds to a function, its termination can correspond to a return of the function to the calling function or the main function.

[0149] As disclosed herein, the term "storage medium," "computer readable storage medium," or "non-transitory computer readable storage medium" can represent one or more devices for storing data, including read only memory (ROM), random access memory (RAM), magnetic RAM, core memory, magnetic disk storage mediums, optical storage mediums, flash memory devices, and / or other tangible machine readable mediums for storing information. The term "computer-readable medium" can include, without being limited to, portable or fixed storage devices, optical storage devices, and various other mediums capable of storing, containing or carrying instruction(s) and / or data.

[0150] Furthermore, example embodiments can be implemented by hardware, software, firmware, middleware, microcode, hardware description languages, or any combination thereof. When implemented in software, firmware, middleware or microcode, the program code or code segments to perform the necessary tasks can be stored in a machine or computer readable medium such as a computer readable storage medium. When implemented in software, a processor or processors will perform the necessary tasks. For example, as described above, according to one or more example embodiments, at least one memory can include or store computer program code, and at least one memory and the computer program code can be configured, with at least one processor, to cause a network element or network device to perform the necessary tasks. Furthermore, a processor, memory, and example algorithms encoded as computer program code serve as a means for providing or causing the performance of operations discussed herein.

[0151] Code segments of the computer program code can represent procedures, functions, subprograms, programs, routines, subroutines, modules, software packages, classes, or any combination of instructions, data structures or program statements. A code segment can be coupled to another code segment or a hardware circuit by the passage of information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, etc. can be passed, forwarded, or transmitted via any suitable means including memory sharing, message passing, token passing, network transmission, etc.

[0152] The terms "comprise" and / or "have", as used herein, are defined as comprising (i.e., open language). The term "coupled", as used herein, is defined as connected, although not necessarily directly, and not necessarily mechanically. Terms derived from the word "indicate", such as "indicated" and "indicating", are intended to cover all various technologies that can be used to convey or reference the indicated object / information. Some, but not all, examples of technologies that can be used to convey or reference the indicated object / information include: communication of the indicated object / information, communication of an identifier of the indicated object / information, communication of information used to generate the indicated object / information, communication of some portion or part of the indicated object / information, communication of some derivative of the indicated object / information, and communication of some symbol representative of the indicated object / information.

[0153] According to example embodiments, a user equipment, other network element, etc. can be (or include) hardware, firmware, hardware executing software, or any combination thereof. Such hardware can include processing or control circuitry such as, but not limited to, one or more processors, one or more CPUs, one or more controllers, one or more ALUs, one or more DSPs, one or more microcomputers, one or more FPGAs, one or more SOCs, one or more PLUs, one or more microprocessors, one or more ASICs, or any other device capable of responding to and executing instructions in a defined manner.

[0154] Benefits, other advantages and solutions to problems have been described above with regard to specific embodiments. However, the benefits, advantages, solutions to problems, and any element(s) that causes or contributes to such benefit, advantage, or solution, or causes such benefit, advantage, or solution to become more pronounced, are not to be construed as a critical, required, or essential feature or element of any or all the claims.

Claims

1. A controller, comprising: At least one processor; A memory coupled to at least one processor, the memory storing computer-executable instructions; and At least one processor is configured to execute computer-executable instructions to cause the controller to: Identify clinical driving scenarios associated with percutaneous devices; as well as The driving characteristics associated with the percutaneous device are set based on the clinical driving scenario and information included in the driving profile, including information in the driving profile that associates a specific clinical driving scenario with a specific driving characteristic.

2. The controller according to claim 1, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: The clinical driving scenario is determined based on location information indicating the distance at which the percutaneous device is inserted into the patient's body.

3. The controller according to claim 2, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: Clinical driving scenarios are determined by comparing the distance the percutaneous device is inserted into the patient with the estimated length of the patient's blood vessels.

4. The controller according to claim 2, wherein: The location information includes at least one of the following: information indicating the position of the arm of the imaging system relative to the patient, the positioning of the percutaneous device manipulator relative to the patient, the position of the tube shell along the drive shaft of the percutaneous device manipulator, image recognition of a mark on the patient, or image recognition of a mark on the percutaneous device.

5. The controller according to claim 1, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: Receive user control signals from the driver interface, wherein the user control signals indicate a requested movement of the transdermal device controlled by the controller; and The driving characteristics of the percutaneous device are set by modifying the user control signals based on the clinical driving scenario and information included in the driving profile.

6. The controller according to claim 1, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: The clinical driving scenario is determined based on at least one of the field of view of the imaging system or the position of the imaging system relative to the patient, wherein the field of view of the imaging system represents the area between the entry point of the percutaneous device into the patient's body and the patient's head.

7. The controller according to claim 1, wherein, The information included in the driver profile includes: Information that adjusts specific driving characteristics in specific clinical driving scenarios.

8. The controller of claim 7, wherein the specific clinical driving scenario includes at least one of the following: the type of percutaneous device, the configuration of the percutaneous device, the distance at which the percutaneous device is inserted into the patient, or whether the distal portion of the percutaneous device is still entirely within the existing percutaneous device.

9. The controller according to claim 7, wherein, The specific driving characteristic includes at least one of the following: Peak speed, peak acceleration, jerk, peak rotational speed, peak rotational acceleration, ratio per input displacement, maximum absolute displacement, maximum force, maximum linear displacement, or rotation lock.

10. A controller, comprising: At least one processor; A memory coupled to at least one processor, the memory storing computer-executable instructions; and At least one processor is configured to execute computer-executable instructions to cause the controller to: Determine the distance at which the percutaneous device is inserted into the patient's body; Receive user control signals from a driver interface, wherein the driver interface is configured to control the movement of the transdermal device in response to user interaction with the driver interface; The user control signal is adjusted based on the distance the percutaneous device is inserted into the patient's body; and An adjusted user control signal is sent to a power device, which is configured to move the transdermal device according to the adjusted user control signal.

11. The controller according to claim 10, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: The distance at which the percutaneous device is inserted into the patient is determined based on kinematic information.

12. The controller according to claim 11, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: The distance at which the percutaneous device is inserted into the patient is determined at least in part based on the position of the imaging system relative to the patient.

13. The controller according to claim 11, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: The distance at which the percutaneous device is inserted into the patient is determined, at least in part, based on the positioning of the percutaneous device manipulator system relative to the patient.

14. The controller according to claim 11, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: The distance at which the percutaneous device is inserted into the patient is determined at least in part based on the displacement of the tubing along the drive shaft of the percutaneous device manipulation system.

15. The controller according to claim 10, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: An adjusted user control signal is generated by altering the user control signal based on at least one of the field of view of the imaging system or the position of the imaging system relative to the patient, wherein the field of view of the imaging system represents the area between the entry point where the percutaneous device is inserted into the patient and the patient's head.

16. The controller according to claim 10, wherein, At least one processor is also configured to execute computer-executable instructions to cause the controller to: Adjusted user control signals are generated based on profile information included in the driver profile, which includes first information relating the distance the percutaneous device is inserted into the patient to the movement characteristics of the percutaneous device.

17. The controller according to claim 16, wherein, The profile information included in the driver profile also includes: The second information associates the mobility characteristics of the percutaneous device with at least one of the safe loading location of the percutaneous device, the type of percutaneous device, or the configuration of the percutaneous device.

18. The controller according to claim 16, wherein: The movement characteristics of the percutaneous device include at least one of the following: peak speed limit, peak acceleration limit, jerk limit, rotational speed limit, per-input displacement ratio, absolute displacement limit, rotational locking, maximum force limit, or linear displacement limit.

19. A robotic device, comprising: An electric motor, configured to apply movement to the transdermal device in response to an electric motor control signal; A driver interface configured to send user control signals to the controller in response to user manipulation of the driver interface; and A controller coupled to the interface between the motor and the drive, wherein the controller is configured to: Identify the clinical driving scenarios associated with the robotic device, where the clinical driving scenarios include the distance the percutaneous device is inserted into the patient; The drive characteristics of the robotic device are set based on the clinical drive scenario and the information included in the drive profile, which includes information that associates a specific clinical drive scenario with a specific drive characteristic. as well as Motor control signals are generated based on driving characteristics.

20. The robot device according to claim 19, wherein, The electric motor is also configured to: Movement is applied to the percutaneous device by moving the housing coupled to the motor along the drive shaft in response to a motor control signal, wherein the movement of the housing causes the percutaneous device to move.

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